Micro-volume syringe priority review application has been announced by the CMDE

Micro-volume syringe priority review application has been announced by the Center for Medical Device Evaluation (CMDE) under the National Medical Products Administration (NMPA) on October 18, 2024. This article aims to provide an overview of the recent announcements, its potential impacts on manufacturers with products in China, and key information on medical device priority review process for regulatory and quality assurance managers.

The product under the priority review process is a micro-volume syringe submitted by Mei Wan Ophthalmic Surgery Co., Ltd. This product stands out because this medical device is clinically urgently needed and for which no product of the same kind has been approved for registration in China.

Here are other recent examples on medical device priority review:

Priority approval process for medical devices

The Priority Approval Procedure for Medical Devices, issued by the State Food and Drug Administration (former NMPA) in October 2016 and effective from January 1, 2017, outlines a faster approval process for specific types of medical devices. The procedure, consisting of 17 articles, focuses on the following key points:

1. Scope of Priority Approval: Devices for diagnosing or treating rare diseases, malignant tumors, unique diseases of the elderly, pediatric applications, and those with clinical urgency are eligible. Additionally, devices in national scientific or research projects may also qualify.
2. Approval Procedures: Applicants submit documentation, and the process includes audits, public announcements, and expert reviews. Priority is given based on the product’s alignment with specific criteria, and provincial authorities handle quality system verification.
3. Special Considerations: Devices for rare diseases, elderly care, and urgent clinical needs are reviewed by clinical experts to determine prioritization.
4. Relationship with Other Approval Procedures: This procedure is distinct from the emergency and innovative medical device approval processes, although it operates in parallel with the latter, giving applicants flexibility in choosing the appropriate route for their product.

What this means for manufacturers

1. Explore Priority Review Opportunities: If your company has a medical device addressing unmet clinical needs in China, exploring the priority review pathway could accelerate your market entry. Mei Wan’s success shows that this is an avenue for fast-tracking approval, particularly for devices with no direct competitors in China.
2. Stay Abreast of Regulatory Announcements: Regulatory affairs teams must keep an eye on the NMPA’s announcements to identify trends in approvals and prioritize devices in development accordingly. This latest approval highlights that China continues to focus on addressing gaps in the availability of critical medical devices.
3. Engage with Stakeholders: In case of any objections or concerns regarding priority reviews, manufacturers have the opportunity to raise them during the public announcement period. Companies should be proactive in evaluating newly approved devices that could affect their market positioning and filing objections if necessary.

How to submit your objections

Objections can be raised during the public announcement period by any organization or individual by submitting the Medical Device Priority Approval Objection Form to the following email: gcdivision@cmde.org.cn. Objections must be submitted before October 25, 2024. If an objection is accepted, the priority approval application will fail, and this device must follow the standard review process. If no objections are raised, the device will proceed smoothly through the priority review process.

Further information

Read the original CMDE announcement on Mirco-volume syringe priority review announced by the CMDE.

Read the CMDE announcement on priority review procedure for medical devices.

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